WO2002083157A1 - Plasma sanguin humain exempt de groupe sanguin et son procede de preparation - Google Patents

Plasma sanguin humain exempt de groupe sanguin et son procede de preparation Download PDF

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Publication number
WO2002083157A1
WO2002083157A1 PCT/CN2002/000264 CN0200264W WO02083157A1 WO 2002083157 A1 WO2002083157 A1 WO 2002083157A1 CN 0200264 W CN0200264 W CN 0200264W WO 02083157 A1 WO02083157 A1 WO 02083157A1
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WO
WIPO (PCT)
Prior art keywords
plasma
type
parts
blood
bloodless
Prior art date
Application number
PCT/CN2002/000264
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English (en)
Chinese (zh)
Inventor
Jianchuan Ma
Zuying Du
Original Assignee
Jianchuan Ma
Zuying Du
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=4655626&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2002083157(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Jianchuan Ma, Zuying Du filed Critical Jianchuan Ma
Publication of WO2002083157A1 publication Critical patent/WO2002083157A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/14—Blood; Artificial blood
    • A61K35/16—Blood plasma; Blood serum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/08—Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock

Definitions

  • the invention relates to a bloodless human plasma suitable for transfusion to patients of various blood types to supplement human blood and a preparation method thereof, and belongs to a human plasma product. Background technique
  • the plasma can be universally used for patients of various blood types regardless of blood type, which brings great convenience to the use of plasma.
  • the production of this universal plasma mainly uses the mixing of type A and type B plasmas, and little or no type AB plasma is used, and type 0 plasma is not used at all, which makes the source of raw materials for blood paddle production very restricted.
  • Plasma has not been tested for anti-A and anti-B agglutination titers, so there are still some gaps from actual clinical use.
  • the plasma does not mention the yield of coagulation factors, which is an important factor affecting the coagulation function of the recipient.
  • the object of the present invention is to provide a bloodless human plasma and a method for preparing the same in view of the shortcomings of the prior art.
  • the bloodless fresh frozen human plasma or bloodless lyophilized human plasma can be made according to needs.
  • the raw materials are widely available, and they are fully practical, safe and effective for clinical use.
  • the objective of the present invention is achieved by the following technical scheme: It mainly includes four blood types of A, B, O, and AB, or three blood types of A, B, and AB, or two blood types of A and B, 0, and AB. Blood paddles are mixed according to the following volume ratio, and after virus inactivation, an appropriate amount of protective agent is added: Type A plasma
  • Type A plasma 3-5 parts Type O plasma 0.5-2 parts.
  • the dosage form of the plasma of the present invention is a fresh frozen plasma preparation or a lyophilized plasma preparation, and the bloodless lyophilized plasma of the present invention is in a dry powder form.
  • the agglutination titer of the blood paddle of the present invention is: ⁇ Anti-A l: 4-1: 8; anti-B l: 8-1: 16.
  • the virus inactivation method according to the present invention is: an S / D inactivation method using an organic solvent / detergent, the specific steps are as follows: 1% TNBP plus 1% TritonX-100 is used to treat plasma at 3CTC for 4 hours, and then The organic solvent TNBP was extracted with vegetable oil (soy oil), and the non-ionic detergent TritonX-100 was removed by PrepC18 solid phase chromatography, so that the residual amount of S / D was lower than the specified standard.
  • the S / D inactivation method can effectively inactivate the lipid-enveloped virus in plasma, and has fewer adverse reactions after infusion into the human body, and has no risk of transmitting hepatitis B, hepatitis C, and AIDS.
  • the protective agent in the present invention is: any one or more of calcium chloride, sucrose, mannitol, glucose and glutathione.
  • the preparation process of the invention is as follows: the qualified plasma collected is quickly stored at 30 ° C and frozen, and the four blood group plasmas are mixed according to the volume ratio, and the virus inactivation treatment is performed by the S / D method to remove virus inactivation Protective agent is added, concentrated by ultrafiltration, and finally sterilized and packed, stored at low temperature (-30 ° C), and it becomes a fresh frozen human plasma preparation.
  • an appropriate amount of protective agent is added before the virus inactivation treatment by the S / D method.
  • the ultrafiltration concentration is performed first, and then the protective agent is added, and the bacteria are separated and packed.
  • spin-freeze at a temperature of ⁇ -30 ° C, and then lyophilize at a temperature of -30 ° C to 32 ° C and ⁇ 50 hours to prepare a freeze-dried human blood paddle preparation.
  • the positive effects and features of the present invention are: 1.
  • the present invention is made by mixing four blood types of plasma, and its raw material sources are more extensive; 2.
  • the anti-A, The anti-B antibody (lectin) is neutralized, diluted, and reduced or removed during the preparation process.
  • its anti-A agglutination titer and anti-B agglutination titer are both below 1: 8 , Fully meets the human blood transfusion standard of 1:16, and can be used for clinical diseases of various blood types. It is convenient and simple to use for human transfusion; 3.
  • S / D virus inactivation is not only a simple method, but also can effectively inactivate and eliminate blood-borne viruses such as HBV, HCV, and HIV in plasma, ensuring clinical use.
  • Safety 4.
  • the raw material plasma is stored at 30 ° C and stored frozen, and an appropriate amount of protective agent is added.
  • low temperature spin-freezing and time-limited freezing can be used at the same time.
  • the active coagulation factor is free from the influence of chemical factors.
  • the recovery rate of fibrinogen, factor V, factor VIII, factor IX, factor X and other major coagulation factors is above 70%, which is beneficial to The coagulation mechanism of the donor is enhanced to ensure the effectiveness of the plasma product.
  • the lyophilized human plasma of the present invention has the characteristics of long storage time, convenient transportation, suitable for combat readiness, and convenient use.
  • the mixed human blood paddles of the above groups all meet the requirements of bloodless human plasma.
  • the plasma dosage forms of the above examples are fresh frozen human plasma preparations or lyophilized human plasma preparations.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Hematology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Cell Biology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Virology (AREA)
  • Immunology (AREA)
  • Developmental Biology & Embryology (AREA)
  • Biotechnology (AREA)
  • Biomedical Technology (AREA)
  • Zoology (AREA)
  • Diabetes (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

L'invention porte sur un plasma sanguin humain exempt de groupe sanguin indiqué pour la transfusion à des patients présentant différents groupes sanguins afin de leur apporter du sang et sur son procédé de préparation. Les produits de cette invention sont obtenus par incorporation d'agents de protection dans le plasma sanguin de groupes sanguins A, B, O et AB ou de groupes sanguins A, B et AB ou de groupes sanguins A et B, O ou AB. L'invention allie commodité et grande variété de ressources de matières premières. Elle fait preuve d'un haut débit de récupération de différents facteurs de coagulation, trouve une application clinique, et est d'usage général, fiable et efficace.
PCT/CN2002/000264 2001-04-18 2002-04-17 Plasma sanguin humain exempt de groupe sanguin et son procede de preparation WO2002083157A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CNB011066377A CN1207004C (zh) 2001-04-18 2001-04-18 通用型冻干血浆及其制备方法
CN01106637.7 2001-04-18

Publications (1)

Publication Number Publication Date
WO2002083157A1 true WO2002083157A1 (fr) 2002-10-24

Family

ID=4655626

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2002/000264 WO2002083157A1 (fr) 2001-04-18 2002-04-17 Plasma sanguin humain exempt de groupe sanguin et son procede de preparation

Country Status (2)

Country Link
CN (1) CN1207004C (fr)
WO (1) WO2002083157A1 (fr)

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114617903A (zh) * 2022-03-15 2022-06-14 中国人民解放军总医院第一医学中心 一种用于血浆冻干的组合物及其应用
US11604026B2 (en) 2019-03-14 2023-03-14 Terumo Bct Biotechnologies, Llc Lyophilization loading tray assembly and system
US11634257B2 (en) 2017-10-09 2023-04-25 Terumo Bct Biotechnologies, Llc Lyophilization container and method of using same
US11806431B2 (en) 2014-09-19 2023-11-07 Velico Medical, Inc. Formulations and methods for contemporaneous stabilization of active proteins during spray drying and storage
US11841189B1 (en) 2022-09-15 2023-12-12 Velico Medical, Inc. Disposable for a spray drying system
US11975274B2 (en) 2022-09-15 2024-05-07 Velico Medical, Inc. Blood plasma product
US11998861B2 (en) 2022-09-15 2024-06-04 Velico Medical, Inc. Usability of a disposable for a spray drying plasma system

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005058334A1 (fr) * 2003-12-19 2005-06-30 Octapharma Ag Plasma sanguin inactive de virus universellement applicable produit a partir de portions de plasma non-caucasien
CN100431550C (zh) * 2005-01-12 2008-11-12 马建川 通用型新鲜冰冻血浆
FR2963737B1 (fr) * 2010-08-16 2013-04-05 Etat Francais Ministere De La Defense Service De Sante Des Armees Procede de lyophilisation de plasma sanguin
CN105832768A (zh) * 2015-08-11 2016-08-10 杜祖英 具有多种功能的人血浆及其制备方法

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4664913A (en) * 1982-05-24 1987-05-12 Xoma Corporation Method for treating plasma for transfusion
CN1042474A (zh) * 1988-11-10 1990-05-30 济南军区药物研究中心 果胶代血浆及制备方法
CN1272061A (zh) * 1997-08-05 2000-11-01 奥克塔法马有限公司 通用血浆

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4664913A (en) * 1982-05-24 1987-05-12 Xoma Corporation Method for treating plasma for transfusion
US4664913B1 (fr) * 1982-05-24 1990-01-30 Xoma Corp
CN1042474A (zh) * 1988-11-10 1990-05-30 济南军区药物研究中心 果胶代血浆及制备方法
CN1272061A (zh) * 1997-08-05 2000-11-01 奥克塔法马有限公司 通用血浆

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
DONG YUANYI ET AL.: "The use of ABO universally applicable blood in emergency treatment", LIAONING JOURNAL OF MEDICINE, vol. 10, no. 6, 1996, pages 307 - 308 *

Cited By (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11806431B2 (en) 2014-09-19 2023-11-07 Velico Medical, Inc. Formulations and methods for contemporaneous stabilization of active proteins during spray drying and storage
US11634257B2 (en) 2017-10-09 2023-04-25 Terumo Bct Biotechnologies, Llc Lyophilization container and method of using same
US11815311B2 (en) 2019-03-14 2023-11-14 Terumo Bct Biotechnologies, Llc Lyophilization container fill fixture, system and method of use
US11609043B2 (en) 2019-03-14 2023-03-21 Terumo Bct Biotechnologies, Llc Lyophilization container fill fixture, system and method of use
US11740019B2 (en) 2019-03-14 2023-08-29 Terumo Bct Biotechnologies, Llc Lyophilization loading tray assembly and system
US11747082B2 (en) 2019-03-14 2023-09-05 Terumo Bct Biotechnologies, Llc Multi-part lyophilization container and method of use
US11604026B2 (en) 2019-03-14 2023-03-14 Terumo Bct Biotechnologies, Llc Lyophilization loading tray assembly and system
US11609042B2 (en) 2019-03-14 2023-03-21 Terumo Bct Biotechnologies, Llc Multi-part lyophilization container and method of use
US11994343B2 (en) 2019-03-14 2024-05-28 Terumo Bct Biotechnologies, Llc Multi-part lyophilization container and method of use
CN114617903B (zh) * 2022-03-15 2024-05-24 中国人民解放军总医院第一医学中心 一种用于血浆冻干的组合物及其应用
CN114617903A (zh) * 2022-03-15 2022-06-14 中国人民解放军总医院第一医学中心 一种用于血浆冻干的组合物及其应用
US11841189B1 (en) 2022-09-15 2023-12-12 Velico Medical, Inc. Disposable for a spray drying system
US11975274B2 (en) 2022-09-15 2024-05-07 Velico Medical, Inc. Blood plasma product
US11913722B1 (en) 2022-09-15 2024-02-27 Velico Medical, Inc. Rapid spray drying system
US11913723B1 (en) 2022-09-15 2024-02-27 Velico Medical, Inc. Baffle plate used in a disposable for a spray drying system
US11998861B2 (en) 2022-09-15 2024-06-04 Velico Medical, Inc. Usability of a disposable for a spray drying plasma system

Also Published As

Publication number Publication date
CN1321468A (zh) 2001-11-14
CN1207004C (zh) 2005-06-22

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